CN102200536A

CN102200536A - Device for detecting analyzed objects in test liquid samples

Info

Publication number: CN102200536A
Application number: CN2010101550710A
Authority: CN
Inventors: 胡林; 胡海鹏; 吴银飞
Original assignee: ABON Biopharm Hangzhou Co Ltd
Current assignee: ABON Biopharm Hangzhou Co Ltd
Priority date: 2010-03-25
Filing date: 2010-03-25
Publication date: 2011-09-28
Anticipated expiration: 2030-03-25
Also published as: US11131662B2; US20180372729A1; WO2011116706A1; CN102200536B; EP2550105B1; US10073088B2; CN105044320A; EP2550105A4; US20130045501A1; CN105044320B; CA2794234C; ES2728462T3; CA2794234A1; EP2550105A1

Abstract

The invention relates to a device for detecting analyzed objects in test liquid samples, which comprises a sample cavity, a test cavity and a through hole, wherein the sample cavity is used for collecting or storing liquid samples; the test cavity is used for accommodating test components; and the through hole can be opened or self-sealed. In the invention, a situation that whether the liquid samples in the sample cavity pass through the through hole and then get into the test cavity is controlled and adjusted through opening or sealing the through hole.

Description

The pick-up unit of analyte in the test liquid samples

Technical field

The invention belongs to the liquid sample assembling sphere, belong to the field of collecting liquid sample and detecting analyte in the sample especially, especially detect the metabolin that whether contains the drug abuse material in the sample or the quick diagnosis of women's gestation aspect and detect.

Background technology

In recent years, pick-up unit is made the body fluid that is used for detecting the people in a large number, urine for example, the analyte in saliva or the blood, for example indicator substance of drug abuse or disease.Traditional like this pick-up unit need be collected in liquid sample to a container usually, inserts testing element in the liquid then and then takes out and read test result on (with the naked eye see or read with machine) testing element.Might allow the operator by sample contamination like this.Use this pick-up unit except being used by professional testing staff, do not had the people of professional experiences to use by some gradually, for example use in the family, this just need provide a kind of operation simpler, and testing result is pick-up unit more accurately.

Summary of the invention

The present invention provides a kind of simple to operate in order to overcome the deficiency of existing product, the device for fast detecting that can allow ordinary consumer accept.

A kind of pick-up unit of one aspect of the present invention comprises and collecting or the chamber of storaging liquid sample; Test chamber and can opening or the through hole of oneself's sealing.Oneself by the control through hole seals or opens fluid transfer sample between sample chamber and test chamber.For example, when through hole was opened, sample chamber and test chamber were in liquid communication by through hole, and the partially liq sample can flow into test chamber by through hole and contact with testing element.Perhaps, in the time of the through hole oneself closure of opening or oneself's sealing, sample chamber can not be in liquid communication by through hole and test chamber, and liquid sample can not flow in the test chamber by through hole.For example, in a selectable scheme, when through hole was in first state, through hole was self-closure or sealing state, when through hole is in second state, was in the closed through hole of oneself and was opened, and allowed through hole be in opened state.First state can be that through hole is in that nature is not subjected to external force or the external force that is subjected to is not enough to allow oneself's sealing or closed through hole open; Second state can be that through hole has been subjected to external force and is forced to open.Certainly, in another selectable scheme, after the external force that allows through hole be in second state disappeared, through hole can be got back to first state again, and promptly through hole is got back to the state that the oneself is closed or seal again from open state.

Through hole with above-mentioned one or more functions can realize that the oneself seals or is opened owing to self material of forming throughhole portions is different under certain condition.For example through hole is to be made of resilient material, on resilient material, use standardized osculum of blade, under the state of nature that is not having external force, because the character of material self, osculum has the ability of self shrinking, allow osculum be in sealing or closed state, during this time the liquid sample in the sample chamber can not enter in the test chamber by osculum.When the Change Example of this resilient material generation shape as the situation that is subjected to external force under, or the character of material changes, for example change of external environment, osculum is opened, the liquid sample in the sample chamber just can enter in the test chamber by osculum like this, finishes to detect and chemically examines.

In some embodiments, through hole can be positioned on the flexible member, when flexible member is in first state, through hole is owing to the elasticity of self is in oneself's sealing or oneself's closure, when flexible member was in second state, through hole was opened, and formed fluid passage in sample chamber and between in the test chamber, thereby the liquid sample in the sample chamber just can enter in the test chamber by through hole, finishes and detects chemical examination.At one more specifically in the mode, first state of flexible member is a state of nature; When flexible member was in second state, flexible member was subjected to the change of external force generation shape.When flexible member in the raw the time, the osculum of scratching with pocket knife in advance on flexible member shrinks naturally, is in sealing state.When flexible member was subjected to external force pressure, because the character of self, the osculum of contraction was opened, and constitutes passage like this between sample chamber and test chamber, and the liquid sample in the sample chamber can enter into test chamber by the osculum that is opened.In some modes, flexible member can also be in the third state, and when flexible member was the third state, the through hole that is opened oneself was again got back to sealing, allows the interior liquid of sample chamber not enter test chamber by through hole so again.The sealing that this through hole is in the third state can be get back under the state of nature self performance and sealed, can also be other modes by motive seal.The external force that for example affacts on the flexible member disappears or reduces to the through hole that is opened and can become closure or sealing state by self-dependent screen resilience.

Flexible member can be made up of resilient material, and resilient material can be to comprise plastics, rubber or silica gel.Rubber include but not limited to, one or more in natural rubber, styrene-butadiene rubber, butadiene rubber, neoprene, nitrile rubber, butyl rubber, EP rubbers, fluororubber, polyurethane rubber, thiokol, epichlorohydrin rubber or the latex.Flexible member also can be formed and also had an ability that is implemented in following function by other material, promptly on resilient material, open a through hole or osculum, shrink to form sealing or closure state at first kind of state lower small mouth oneself, allow the liquid sample in the sample chamber not enter into test chamber by the through hole that shrinks; When opening at second kind of state lower through-hole, the liquid sample in the sample chamber can enter into test chamber by open osculum.Being in mode that oneself sealing or closed through hole be opened and can being masterpiece by the outside is used on the through hole or forms on other positions of via material allowing through hole that the change of state has taken place.The external force of this effect directly, also can be indirect.

In other embodiments, flexible member is " nipple " a shape, through hole is positioned on the sidewall of nipple, when its first state in the raw the time, nipple is towards the right side at this moment, owing to constitute material self property or self shape of nipple, through hole is in sealing state, at this moment, the liquid in the sample chamber can not enter in the test chamber by the through hole on the nipple.When nipple be reversed or effect in external force under force nipple towards a left side, second state for nipple, at this moment the inside surface of nipple is turned up and is become outside surface, the opening that is in self seal this time is opened owing to the shape of nipple changes, and so just can allow the liquid in the sample chamber enter in the test chamber by the through hole on the nipple.Certainly, can also be to allow nipple return first state from second state, the through hole on the nipple is changed into the state of oneself's sealing again from open mode like this.

Whether in some embodiments, device can also comprise a bar, control through hole by moving of control lever and seal or open, thereby whether the liquid sample in the control sample chamber flow in the test chamber by through hole.For example, when bar was positioned at primary importance, through hole kept sealing state, and the interior liquid sample of sample chamber in this time can not enter into test chamber by through hole and contact with testing element; When the position of bar moved to the second place from primary importance, the position change of bar caused the through hole of sealing state to be opened, and contacted with testing element thereby allow the interior liquid sample of sample chamber enter into test chamber by the through hole of opening.Through hole can be positioned on the flexible member more specifically in the mode at one, and when bar was positioned at primary importance, the through hole on the flexible member was because self elasticity and shrink naturally and form the through hole that seals; When bar when primary importance moves to the second place, bar allows the through hole that seals naturally originally be opened by flexible member generation elastic deformation, can control whether carry out liquid flow between sample chamber and the test chamber like this.

In some other embodiments, bar is connected with piston, changes the change of the position that drives bar by position of piston.The position change of bar can be from top to bottom, or from top to bottom, perhaps from right to left, perhaps from left to right.The change of piston position can be from top to bottom, or from top to bottom, perhaps from right to left, perhaps from left to right.

In some other embodiments, pick-up unit can also comprise a liquid transfer chamber, and the liquid sample in the sample chamber flow in the test chamber by transfer chamber, can oneself's sealing or a through hole opening be positioned at the transmission of controlling liquid on the transfer chamber.When through hole was in first state, through hole was because the character of self material and self seal, and like this, the liquid sample in the sample chamber can not enter into test chamber by through hole; When through hole was in second state, the through hole of sealing was opened, and the liquid sample in the sample chamber just can enter into test chamber by through hole.In the other embodiment, when through hole is in first state, through hole oneself sealing, the liquid transfer chamber communicates with sample chamber, when through hole is in second state, through hole is opened, and the liquid transfer chamber does not communicate with the liquid sample chamber, and the liquid in the liquid transfer chamber communicates with test chamber by the through hole of opening.In mode more specifically, piston can be positioned at the liquid transfer chamber, changes by position of piston to allow the state of flexible member change, thereby allows the state of through hole change.

In the other embodiment, device can also comprise a lid that covers on the sample chamber, and lid covers in the process of sample chamber, allows the through hole of oneself's sealing be opened thereby lid drives moving of bar.

Test chamber is meant space or the compartment that contains testing element.In one embodiment, test chamber can be positioned on the lid.In other embodiment, test chamber can be separated with lid, but its functional equivalent is in the chamber that is positioned on the lid.For example, in the embodiment that substitutes, test chamber can be to be positioned at the sample chamber the inside, perhaps in the outside of sample chamber.A kind of light of " transparent " expression material that can see through, thus under general indoor light, people's bore hole can be seen the object of transparent material back, and use the people of this device can see test result under this transparency window." cup " not only refers to conventional circular or oval-shaped container, also refers to the container of Any shape.Therefore, cup also can be square, perhaps is suitable for realizing any configuration of cup function.Secondly, lid can include helicitic texture as herein described, but also can be the buckle structure that snaps into the top of cup, or a kind of cork that can be tucked into the cup room and be fixed to cup by its bulging force.When adopting helicitic texture, the degree of depth of screw thread is not what limit, as long as can be fixed to lid on the cup, screw thread can be multi-turn, a circle even less than one circle.But in some embodiments, cup and lid all are circular.

Another aspect of the present invention provides a kind of method that detects analyte in the sample, comprising: a kind of device is provided, and this device comprises: a test chamber that is used to accommodate testing element; Collecting chamber that is used to collect liquid sample and one can oneself's sealings or the through hole that is opened;

Open through hole, allow the partially liq sample flow into test chamber by through hole or to allow through hole oneself sealing from collecting chamber, allow collecting chamber not with the test chamber liquid communication.

Optionally, method also comprises: described through hole is positioned on the flexible member; When allowing flexible member be in first state, through hole oneself sealing; When allowing through hole be in second state, through hole is opened.This method also comprises allows a bar act on the through hole, and catch bar moves to the second place from primary importance, thereby allows through hole change to second state from first state.Optionally, allow a bar act on the flexible member, catch bar moves to the second place from primary importance, thereby allows flexible member change to second state from first state.

Optionally, method also comprises allows through hole become the third state from second state, in the third state, and through hole oneself sealing.

Beneficial effect

Device provided by the invention can allow the pick-up unit operation simpler, is different from existing traditional proving installation.

Description of drawings

Fig. 1 is the perspective view of pick-up unit in specific embodiment of device of the present invention;

The blast structural representation of Fig. 2 for installing shown in Fig. 1;

Fig. 3 A is the device shown in Fig. 1 of the present invention, and through hole is at first state, and piston push rod is at the part section structural representation of primary importance; Fig. 3 B is in the device shown in Fig. 3 A, and through hole is at first state, and piston push rod is at the perspective structure synoptic diagram of primary importance;

Fig. 4 A is in the device shown in Fig. 3 A of the present invention, and through hole is at first state, and piston push rod is in the perspective view of the second place; Fig. 4 B is the cut-away section structural representation of the device shown in Fig. 4 A; Fig. 4 C is the perspective structure synoptic diagram of the device shown in Fig. 4 A;

Fig. 5 A is in the device of specific embodiment of the present invention, and through hole is at second state, and piston is in the perspective view of the second place; Fig. 5 B is the part tangent plane structural representation of the device shown in Fig. 5 A; The perspective structure synoptic diagram of the device shown in Fig. 5 C Fig. 5 A;

Fig. 6 A is the perspective view of nipple element at first state; Fig. 6 B is the cross-sectional view of nipple element first state;

Fig. 7 A is the perspective view of nipple element at second state; Fig. 7 B is the cross-sectional view of nipple element at second state;

Fig. 8 A is the assembling cross-sectional view of piston shown in Fig. 8 C and piston push rod element; Fig. 8 B is another cross-sectional view of assembling of piston shown in Fig. 8 C and piston push rod element; Fig. 8 C is an assembling perspective view (piston rod is a primary importance, and piston is a primary importance) of showing piston and piston push rod element;

Fig. 9 A is the assembling cross-sectional view of piston shown in Fig. 9 C and piston push rod element; Fig. 9 B is another cross-sectional view of assembling of piston shown in Fig. 9 C and piston push rod element; Fig. 9 C is an assembling perspective view (piston rod is the second place) of showing piston and piston push rod element;

Figure 10 A is the cross-sectional view of pick-up unit in specific embodiment of device of the present invention, and flexible member is first state, and wherein through hole is oneself's sealing or closed; Figure 10 B is that flexible member is the perspective view of first state; Figure 10 D is that flexible member is the perspective view of second state, and this moment, through hole was opened; Figure 10 C is in Figure 10 A shown device, and flexible member is second state, wherein the cross-sectional view that is opened of through hole; Figure 10 E is that flexible member is the perspective view of the third state, and flexible member is got back to first state again, and wherein through hole is oneself's sealing or closed.

Figure 11 A is the cross-sectional view of pick-up unit in specific embodiment of device of the present invention, and flexible member is first state, and wherein through hole is oneself's sealing or closed; Figure 11 B is that flexible member is the perspective view of first state; Figure 11 C is in the device shown in Figure 11 A, and flexible member is second state, wherein the cross-sectional view that is opened of through hole; Figure 11 D is that flexible member is the perspective view of second state, and this moment, through hole was opened.

Description of reference numerals:

Pick-up unit 10; Testing element 700;

Lid

800,80; Test chamber 400; 40; Flexible member 30; 13; Designated port 33; Aperture 133; Cup 600; Collecting chamber 601; 61; Cup base 602, cup opening 606; Transfer chamber 500; Transfer chamber one end opening 501; Transfer chamber other end opening 502, chimb is gone in ring along 503 in the transfer chamber bottom; Passage 603; Nipple element 300; Nipple pedestal 301; Nipple sidewall 304; Nipple designated port 303; Nipple chamber 305, nipple top 304;

Bar

204,24,14; Masthead end 205; Nipple groove 306; Piston 200; Piston outer wall 203; First O-ring seal 201; Second O-ring seal 202; First card article, 207, the first card article ends 208; Second card article 206; The second card article end, 209, the first bayonet sockets 105,105 '; Second bayonet socket 104,104 '; Piston push rod 100; Push rod head 101; Piston push rod main body 103; The outer wall 108 of push rod main body; The chamber 210 of piston 200.

Embodiment

In the following detailed description, the explanation of accompanying drawing and corresponding character only is the mode that illustrates that by way of example the present invention can actable specific concrete scheme.We do not get rid of the present invention can also be in any other embodiment in claim scope of the present invention.

On the one hand, the invention provides the pick-up unit of analyte in a kind of tracer liquid sample.This device can detect chemical examination and not pollute other remaining liquid samples liquid sample.And this detection is to finish in a step, does not need the complicated operations step.

With reference to Figure 10, a kind of pick-up unit of the present invention, comprise that a liquid sample is collected or the sample chamber 61 of storaging liquid sample, with a test chamber 40, in test chamber, comprise a testing element 700, testing element can be immune cross flow reagent strip, a flexible member 30 is set between test chamber and sample chamber, this flexible member is a rubber sheet, rubber sheet by sheet is test chamber and sample chamber is separated and do not allow them be in fluid connection, does not promptly have fluid exchange (as Figure 10 A) between them.On rubber sheet, mark the designated port 33 of " ten " subtype in advance with sharp pocket knife, because the external force that is not subjected to external force or is subjected to is little enough big, when the collection in the sample chamber has certain liquid sample 66, designated port 33 still is in first state (as Figure 10 B) that the oneself is closed or seal, in this time, the liquid sample 66 in the sample chamber can not flow in the test chamber by the designated port of " ten " subtype.When rubber sheet was subjected to external force, in the time of for example by a rod-like articles 14 compressing rubber sheet 30, elastic deformations took place in rubber sheet 30, allow the closed designated port 33 of oneself open, and are in second state; In this time, the partially liq sample 67 that is arranged in sample chamber flow into test chamber by the designated port that is opened and contacts with testing element 700, can detect whether contain specific analyte (as Figure 10 C and 10D) in the liquid sample by testing element.After the partially liq sample enters into test chamber, can allow the external force of compressing rubber sheet 30 disappear, for example allow rod-like articles 14 no longer contact rubber sheet, at this moment, the designated port 33 that originally is opened is owing to the elasticity reason is got back to the third state (third state is identical with first state) that the oneself is closed or the oneself seals again, and the liquid that flows to test chamber originally is blocked (as Figure 10 E).The thickness of the flexible member lake rubber sheet that is adopted can be the 0-30 millimeter, also can be the 1-15 millimeter, can also be the 2-5 millimeter, for example is 1 millimeter, 2 millimeters, and 3 millimeters, 5 millimeters, 10 millimeters.The area of designated port can be 1-10cm ²Or 2-5cm ²Choose which kind of material, how to choose the size that suitable thickness or designated port open and can freely select as required, general technology those skilled in the art can finish smoothly according to announcement of the present invention with in conjunction with existing known technology.In present embodiment, in order to make liquid sample more natural and flow into the test chamber by designated port 33 from sample chamber smoothly, on test chamber, can open an aperture, allow test chamber communicate with the atmospheric pressure of environment.In addition, also can allow sample chamber communicate with the external environment atmospheric pressure.When designated port 33 is opened, by means of the pressure of liquid sample self or and test chamber between pressure differential force the partially liq sample to flow in the test chamber by the designated port that is opened.

Figure 11 A-11D is the pick-up unit in another concrete embodiment of the present invention.This proving installation comprises a sample chamber 61, and this sample chamber one end opening is used to receive liquid sample, urine for example, and other end sealing is opened a hole (not shown) on an end of sealing, seal with a size sheet rubber 13 suitable with the hole.Also have in the pick-up unit also to comprise a cavity 40, part cavity 401 is positioned at an end of sample chamber sealing and is positioned at below the sheet rubber 13, and 402 comprise a testing element 700 in another part cavity.On sheet rubber 13, open an aperture 133 in advance, when sheet rubber in the raw or have only under the situation that the sample chamber inner sample liquid exists, aperture 133 is in first state that the oneself is closed or seal, shape is as "-", the liquid sample that be positioned at sample chamber this moment can not enter into test chamber 40 by aperture, as Figure 11 B.In the time of the opening of the lid 80 airtight sample chamber 61 that had a push rod 24 by, along with the rotation of lid, push rod is from moving to the contact sheet rubber and oppressing other place of the opening part or the sheet rubber of sheet rubber 13 gradually.Owing to self flexible reason, this moment, the aperture 133 of oneself's sealing was opened, and was in second state of opening, and the liquid that is arranged in the liquid sample chamber enters into test chamber by aperture 133 and contacts with testing element, as Figure 11 C and 10D.

Selectable, the closed sheet rubber of oneself is oppressed to be opened and not to be directly to realize by push rod, also can be by allowing lid sealing sample chamber, and allow the air pressure on the liquid surfaces in the chamber 61 mutually to external world atmospheric pressure increase, the pressure that increases forces the closed aperture of oneself to be opened indirectly, thereby allows liquid sample enter test chamber.In addition, can also allow the pressure and the external atmosphere pressure of the interior liquid surface of sample chamber be consistent once more, at this moment, the aperture that is opened can be got back to the state that the oneself is closed or seal again because external force disappears, thereby the blocking-up liquid sample flow in the test chamber.Allow the pressure of liquid surface and the method that external atmosphere pressure is consistent again can be to open an aperture on lid in the sample chamber, aperture is by the sealing of plastics cork, when the pressure in the sample chamber increases, the plug seal aperture, when needs reduce pressure, transfer to stopper to be communicated with atmosphere by sample chamber.Thisly allow method and structure that pressure increases at disclosed Chinese patent, open in the application number 200480033286.8, the application all quotes wherein example as one of object lesson of the application.

Fig. 1-7 is proving installation and the method in another embodiment of the present invention.As Fig. 1 and Fig. 2, this device comprises the flexible member 300 of a sample chamber 601 and a test chamber 400 and a nipple shape.Sample chamber 601 and nipple element 300 are positioned at cup 600, the opening 606 of cup is collected liquid sample in sample chamber 601, comprise a passage 603 in the bottom of collecting chamber 601, this passage and a transfer chamber 500 communicate, sample chamber 601 communicates with transfer chamber 500 by passage 603, the shared wall of the bottom of collecting chamber 601 and transfer chamber, passage 603 is positioned on this wall.The both ends open of transfer chamber 500, at flexible member 300 near installation nipple shape on the opening 502 of test chamber 400, on away from the opening of test chamber and be positioned at passage 603 near comprise a piston 200, piston is positioned at the cavity of transfer chamber, piston can be in transfer chamber 500 move left and right.Comprise elastic sealing elements 201,202 on the piston 200, the sealing element is used for sealing the inwall of transfer chamber and the outer wall 203 of piston.Between nipple element 300 and piston 200, define a chamber 900 that receives the liquid sample in the sample chamber by passage 603 like this.

Referring to Fig. 6 A-6B, 7A-7B, the flexible member 300 of nipple shape comprise the part and the base part 301 of a projection, and the part of projection comprises that 302, one through holes of sidewall 304 and top 303 are opened on sidewall 304; Sidewall 304 and top 302 surround a nipple chamber 305.Comprise a groove 306 on the base part 301, the circular protrusion edge 503 of this groove and transfer chamber cooperates, and allows the pedestal of nipple element be installed in hermetically on the end opening 502 of transfer chamber.When the flexible member 300 of nipple shape is positioned at first state, the part of nipple projection, i.e. the chamber of nipple, towards the right side, this moment, through hole 303 was in self-sealing state because the elastic reaction in nipple chamber 305 self.After turning in nipple chamber 305 is shunk also, when top 302 was positioned at the left side of base part 301, the through hole 303 that is in sealing or closure state was opened.In a concrete mode, a push rod 204 is connected as a single entity with piston, and be positioned at the dead ahead at the top 302 of nipple shape flexible member 300, driving push rod 204 when piston moves in transfer chamber from right to left moves from right to left, thereby push rod forces top 302 to move to the left side of pedestal 301 from the right of base part 301.Certainly in other optional modes, through hole also can be opened in other positions, for example other position of top or sidewall except can being bored on the sidewall.

Describe the pick-up unit work principle in detail and how to use below in conjunction with accompanying drawing.

In first state, referring to Fig. 1-3, the top 302 of nipple flexible member is towards the right side, the piston that is in primary importance is positioned at transfer chamber (perhaps being called plunger shaft) 500 and limits a chamber 900 with the nipple flexible member, comprise passage 603 on the sidewall in this chamber 900, the seal element of piston, for example O-

ring seal

201 and 202 allows the outer wall of piston and the inner wall sealing of transfer chamber 500.And piston blow-by passage 603 is shown in Fig. 1 and 3A-3B.At this moment, when collecting liquid sample with device, when liquid sample is full of sample chamber, the partially liq sample flow in the chamber 900 by passage 603, but because through hole 303 is in first state that the oneself is closed or seal on the nipple flexible member 300, liquid sample can not flow in the test chamber 400 by the through hole on the nipple flexible member.Though the liquid sample in the liquid sample chamber has produced certain pressure or pressure to the through hole on the nipple flexible member 300 303, perhaps the top 302 to nipple has also produced pressure simultaneously, and this pressure can't force the through hole of self-isolation or sealing to be opened.In addition, piston 200 has sealed the other end in the transfer chamber 500, so the volume of liquid sample is certain in chamber 900.Certainly, the volume in chamber can be selected arbitrarily, for example is the 1-5 milliliter, 2-10 milliliter or the like.

When in use, referring to Fig. 4 A-4C, draw back piston push rod 100 that flexibly connects with piston 200 and the head 101 that promotes piston push rod, allow piston move to the second place from primary importance.In the process that moves, outer wall 203 seal channels 603 of piston allow top 302 on top one end, the 205 contact nipple flexible members 300 of push rod 204 simultaneously.This moment, chamber 900 was all sealed, and it neither carries out fluid exchange with sample chamber, does not also exchange with test chamber.

Referring to Fig. 5 A-5C, along with piston further moves to the second place, the chamber 305 that the push rod 204 that is connected as a single entity with piston forces the nipple element is from being turned to towards a left side towards the right side, allows the top 304 of nipple element 300 become and be positioned at test chamber 400 from being positioned at chamber 900.Because turning up of nipple element 300 sidewalls, the through hole 303 that be positioned on nipple element 300 sidewalls 304 this moment is in second state of opening, piston mobile forces the liquid sample in the chamber 900 to enter in the test chamber 400 by through hole 303 and contacts with testing element 700, thereby can detect whether comprise analyte in the liquid sample by testing element.At this moment, chamber 900 is a fluid connection with test chamber, but not with sample chamber 601 fluid connections.

In a mode, piston 200 is flexible connection with piston push rod 100, when needs push away stalk 100 and promote piston and move in transfer chamber 500 with piston when, piston push rod 100 is pulled out from plunger shaft 210, then by position limiting structure by between piston 200 and the piston push rod 100 not in relative motion, piston and piston push rod are connected as a single entity like this.When promoting piston push rod 100, piston moves with piston push rod, thereby drives push rod 204 motions that are connected as a single entity with piston.Moving of push rod 204 positions can allow the nipple flexible member of first state that is in the closed or sealing of oneself change to second state like this.The concrete description of face as follows.

Referring to Fig. 8 A-8C and Fig. 9 A-92, piston 200 is cylindrical, comprises the cavity 210 of hollow, has two grooves that seal element 201,202 is installed on the outer wall 203 of piston, and an end of piston is for sealing and to rod shaped structure 204 of outer process.Piston push rod 100 comprise push rod main body 103 be connected with main body cut somebody's hair 101, on the outer wall 108 of push rod main body 103, comprise first bayonet socket 105,105 ' with second bayonet socket 104,104 ' of two teams' correspondence.Bayonet socket is inverted "L" shaped.On the inwall of piston cavity 210, fix two card articles 207,206 respectively.One end of card article has reclinate end 208,209 respectively.When push rod main body 103 was positioned at plunger shaft 210, the end of two card article 207,206 bendings just can be positioned at bayonet socket 105,105, on, this moment, bayonet socket 104,104 ' was vacant not by the state of card article clamping (Fig. 8 B).When needs are operated, pull out to the right with hand and to cut somebody's hair 101, allow push rod main body 103 from piston cavity 210, pull out, hear " coughing " one, the end 208 of expression card article 207,206,209 respectively from first bayonet socket 105,105, on move on second bayonet socket 104 and 104 ' on, and be connected to

bayonet socket

104 and 104 on the push rod main body 103 '.And then cut somebody's hair 101 left, because push rod main body 103 was connected as a single entity with piston 200 and no longer was in relative active state this moment, so piston is pushed to the second place by push rod main body 103 from primary importance.Like this, the bar 204 that is connected on the piston 200 moves to the second place from primary importance, and the moving of push rod 204 positions can allow the nipple flexible member of first state that is in the closed or sealing of oneself change to second state of opening.

This push rod that flexibly connects with piston not only can be used for the present invention's proving installation, can also be connected with piston separately and apply in other the proving installation.

" sample " that the present invention refers to refer to whether needs chemical examinations exists and (or) analyze any material of analyte concentration, maybe need to determine whether one or more samples exist and (or) material of the analyte of quantity, maybe need to carry out the material of qualitative evaluation.Sample can be liquid sample, for example liquid sample.Liquid sample comprises body fluid, such as blood, serum, blood plasma, saliva, urine, tears, seminal fluid and marrow; Liquid sample also can be a water sample, such as seawater, river, river etc., perhaps from domestic water, municipal water use or service water resource, runoff water or sewage; Sample can be a food sample, such as milk and wine.Mucus, semisolid or solid sample can be used for making liquid, eluate, suspending liquid or leachate equal samples.For example, throat or genitals sample may be dipped in and make sample in the liquid.Sample can comprise potpourri or any relevant potpourri of liquid, solid and gas, such as the cell suspending liquid in dilution or the solution.Sample comprises biological substance, such as cell, microorganism, organelle and biochemical complexes.Liquid sample can be from producing such as solid, semisolid or high-viscosity materials such as soil, ight soil, tissue, organ, biological fluid or other occurring in nature non-liquid samples.For example, these solids or semi-solid samples can be mixed with the suitable solution of dilution one class.Sample can be macerated, freezing and thaw, perhaps other extracting method form liquid samples.Remaining particulate material can use traditional method such as filtration or precipitation to remove.

The analyte that the present invention refers to can be " drug abuse " (DOA) or other have interested material in the sample." drug abuse " (DOA) is meant that the non-medical destination uses medicine (playing the paralysis nerve usually).Abuse these medicines and can cause body ﹠ mind to suffer damage, produce dependence, habit-forming and/or dead.The example of drug abuse comprises cocaine; Amphetamine (for example, black beauty, white amphetamine tablet, dextroamphetamine, dexie, Beans); Crystal methamphetamine (crank, meth, crystal, speed); Barbiturate (as Valium, RochePharmaceuticals, Nutley, New Jersey); Sedative (paramedicines of promptly sleeping); Lysergic acid diethylamide (LSD); Inhibitor (downers, goofballs, barbs, blue devils, yellow jackets, methaqualone); The anti-antidepressant of tricyclic antidepressants (TCA, i.e. imipramine, amitriptyline and doxepin); Hog (PCP); Tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); Opiate (being morphine, opium, codeine, heroin, the hydroxyl dihydrocodeinone); Anxiolytic and hypnotic sedative agent, anxiolytic is that a class is mainly used in anxiety reduction, nervous, frightened, set the mind at rest, have the medicine of hypnosis sedation concurrently, comprise Benzodiazepines (benzodiazepines, BZ), atypia BZ class, merge phenodiazine NB23C class, the tall and erect class of benzene nitrogen, the part class of BZ acceptor, open loop BZ class, diphenylmethane derivatives, the piperazine carboxylic acid salt, the piperidine carboxylic acid salt, Kui azoles quinoline ketone, thiazine and thiazole, other heterocyclic, imidazole type calmness/anodyne, propanediol derivative-carbamates, fatty compound, anthracene derivative etc.Use this device also can be used to detect and belong to medical usage but the detection of overdose easily, as tricyclic antidepressant (imipramine or analog) and Paracetamol etc.Can resolve into different small-molecule substances after these medicines are absorbed by the body, these small-molecule substances are present in the body fluid such as blood, urine, saliva, sweat or there is above-mentioned small-molecule substance in part body fluid.

Testing element 700

Device of the present invention can adopt multiple test-strips, and this is according to the purpose of being disinclined to analyte to be checked and test.Test-strips can roughly be divided into two classes, detects test-strips and the anti-test-strips of mingling.Detect test-strips and comprise the material that is used for detecting sample composition to be checked.Prevent that mingling test-strips comprises the material that is used to detect the sample material characteristic.Two types test-strips all comprises sample application zone and detection zone.

Detect test-strips: multiple detection test-strips can be used among the present invention.Detect the test that test-strips comprises analyte in immune detection or chemical detection and the detection sample.These analytes comprise: the metabolin of drug abuse or hint health status.

For example above-described " drug abuse " be material (DOA).Be the legal medication of medical purpose, but incidental dosage is excessive, also can adopts test-strips of the present invention to detect.These medicines comprise: three rings anti-strongly fragrant dose (imipramine and its analog) and contain the OTC product (medicine of acenol is provided such as the trade mark that is positioned at the washingtonian McNeil-PPC of Pennsylvania, America company and provides) of acetaminophen.This detection can help patient that emergency rescue personnel judges stupor whether by accident excessive use a kind of in these medicines.

Can hint that the metabolin in the urine of health status includes but not limited to creatinine, cholerythrin, nitrite, protein (non-specific), hormone is (as human chorionic gonadotrophin, corpus luteum hormone, follicular stimulating hormone etc.), blood, leucocyte, sugar, heavy metal or toxin, the bacterium composition is (as specific protein or the carbohydrate of Special Category bacterium, such as Escherichia coli O 157: H7, staphylococcus, salmonella, fusobacterium, Campylobacter, monocytosis kytoplasm base (L.monocytogenes), vibrio, or cactus bacillus) and physical property, as pH value and proportion.Any other clinical urine chemical analyte that can adopt the fast detecting mode can be applied in this device.

Detect test-strips various ways can be arranged.Generally speaking, test-strips is made up of absorbent material.This absorbent material comprises sample application zone, raw material district and test results zone.Sample is added to sample application zone and by capillary force wet raw material district.In the raw material district, the sample dissolving also mixes those and detects the necessary raw material of analysans (if existing in the sample).The sample that has mixed raw material continues moistening test result zone.Extra raw material is fixed on test result zone.The reaction of one of first group of raw material in these raw materials and analysans (if present) or raw material district.If there is analyte really in sample, a signal will appear in the test section, otherwise then signal can not occur.

As an example more specifically, the detection test-strips that following United States Patent (USP) or the disclosed data of patented claim are disclosed can be used among the present invention: 5,252,496,5,415,994,5,559,041,5,602,040,5,656,503,5,712,170,5,877,028,5,965,458,6,046,058,6,136,610,6,140,136,6,183,972,6,187,268,6,187,598,6,194,221,6,194,224,6,221,678,6,228,660,6,241,689,6,248,598,6,271,046,6,297,020,6,316,205,6,372,514,6,338,969,6,368,873,6,372,516,6,375,896,6,375,897,6,391,652,6,403,383,6,418,606,6,429,026,6,464,939,6,468,474,6,485,982,6,506,612,6,514,769,6,528,323,6,548,019,6,730,268,2001/0004532,2001/0021536,2001/0023076,2002/0001854,2002/0004019,2002/0031840,2002/0031845,2002/0052050,2002/0085953,2002/0137231,2002/0173047,2002/0132267,2003/0129673,2003/0207466,2004/0018636 and 2004/0191760.

The anti-test-strips of mingling: prevent that mingling test-strips is used to detect sample material characteristic or pollution, for example: temperature, proportion, pH value, oxygenant pollute, glutaconaldehyde pollutes, nitrite pollutes, ascorbic acid usp/bp pollutes and the creatinine pollution.Test purpose for this reason, it is desirable adopting following test-strips.This test-strips has merged those and has been used to detect extra chemical substance or other intention and defeats and detect and the reagent of concealment drug taking behavior.These test-strips can be used in any form, for example immune detection or chemical detection.In some embodiments, can comprise on this test-strips the chemical examination of creatinine and protein to detect whether diluted mistake of urine sample.The anti-test-strips of mingling also can detect Cobastab or other intention and defeats and detect and join material in the urine.These materials comprise: glutaraldehyde, nitrite, chromate, vinegar, trade mark are that commodity (Pfizer by the New York city,U.S provides), sodium bicarbonate, the trade mark of Visine is commodity (the S.C.Johnson company by the Racine city of Wisconsin, USA provides), soft drink, the oxygenant (for example bleaching agent, hydrogen peroxide, pyridine, chromium chloride hydrochlorate) of Drano.

The test-strips of test liquid samples substance characteristics can be used with the present invention.These test-strips comprise be used to transmit the absorbent material of liquid sample by test-strips, with absorbent material mutually fluid connection filtering element, with the raw material pad of filtering element phase fluid connection and one transparency cover optionally.Raw material pad include be used to produce can detected symbol raw material, and transparent plate (if adopt) observation by transparency cover and this device relevant with sample properties of this symbol obtains.Described filtering element can be by the made that can suppression fluid refluxes to absorbent material from raw material pad." suppress reflux " is meant that the Fluid Volume that flows to absorbent material from raw material pad seldom and not can change assay or seldom detects not come out or can not make that this testing result becomes indeterminate from the amount that raw material pad is transferred to the raw material of absorbent material or adjacent raw material pad.Test-strips also can comprise the part that places filtering material and the material that do not get wet between the absorbent material.This material that do not get wet is to reflux to absorbent material from raw material pad in order to suppress sample.Liquid sample transmits because of capillary action and passes whole test-strips." capillary action " is meant that the inside by liquid and wall or material that present technique field personnel know interacts and the physical influence of generation, and this physical influence can cause flow of liquid to cross this material." absorbent material " is meant that the material of easy attraction or absorption fluids and this material are suitable for capillary action fluid is transferred to another place by the somewhere of this material." filtering element " promotes the even diffusion of sample during to raw material pad in sample flow.Thereby promote that successively formation uniformly can detected symbol on raw material pad.Filtering element also suppresses sample and is refluxed to absorbent material by raw material pad, thereby the chemical substance that also suppresses raw material is transferred to another raw material pad by a raw material pad." material does not get wet " is meant the material that the fluid of the quantity that does not allow meeting change testing result passes.The normally mobile barrier of fluid of material does not get wet.

The capillary flow of other type is mingled test-strips and also can be integrated in the device of the present invention.That for example, is disclosed in the following listed reference mingles test-strips and can be applied among the present invention: 2002/0001845,2002/0098512,2002/0155028,2003/0045003,5,922,283,6,248,598,6,514,768,6,537,823 and 6,548,019.

Claims

1. the pick-up unit of analyte in the test liquid samples is characterized in that, comprising: one is used to collect or the sample chamber of storaging liquid sample; A test chamber and a through hole that is used for fluid transfer sample between sample chamber and test chamber that is used to accommodate testing element, wherein, this through hole comprises first and second states, when through hole is in first state, the closed or oneself's sealing of through hole oneself; When through hole was in second state, through hole was opened.

2. device according to claim 1, wherein, when through hole was in second state, the liquid sample in the sample chamber was by through hole and test chamber fluid connection.

3. pick-up unit according to claim 1, wherein, when through hole was in first state, the liquid sample in the sample chamber can not be by through hole and test chamber fluid connection.

4. device according to claim 1, wherein, described through hole is positioned on the flexible member.

5. device according to claim 4, wherein, the material of described formation flexible member is selected from silica gel, plastics, one or more in the rubber.

6. device according to claim 4, wherein, described flexible member has first and second states; When flexible member was first state, through hole was in first state; When flexible member was second state, through hole was in second state.

7. device according to claim 4, wherein, described device also comprises a liquid transfer chamber, described flexible member is positioned at transfer chamber.

8. device according to claim 7, wherein, described flexible member comprises first and second states; When flexible member was first state, through hole was in first state, and sample chamber communicates with the liquid transfer chamber, and test chamber does not communicate with the liquid transfer chamber; When flexible member was second state, through hole was in second state, and test chamber communicates with the liquid transfer chamber, and sample chamber does not communicate with the liquid transfer chamber.

9. device according to claim 8, wherein, when through hole is in first state, sample chamber communicates with the liquid transfer chamber by passage.

10. device according to claim 6, wherein, this device also comprises a bar that allows flexible member be in first or second state.

11. device according to claim 10, wherein, when bar was in primary importance, flexible member was first state; When bar when primary importance moves to the second place, flexible member is changed into second state from first state.

12. device according to claim 11, wherein, this device also comprises a lid that covers the collection well opening, and when cover cap is incorporated on the sample chamber, lid moves to the second place by bar from primary importance.

13. device according to claim 4, wherein, this device also comprises a lid that covers the opening of collection well, and when cover cap is incorporated on the sample chamber, lid changes to second state by the through hole on the flexible member from first state.

14. device according to claim 1, wherein, described test chamber is positioned at outside the collection well.

15. device according to claim 1, wherein, testing element is the immunoassay reagent strip.

16. device according to claim 6, wherein, flexible member also comprises the third state, and when flexible member was in the third state, the through hole on the flexible member was the closed or oneself's sealing of oneself.

17. device according to claim 4, wherein, flexible member is the nipple shape, and it comprises the nipple chamber that is made of sidewall and top; Described through hole is positioned on the sidewall of nipple.

18. device according to claim 17, wherein, this device also comprises a transfer chamber and is connected with the piston of bar that transfer chamber comprises two openings, an opening of described nipple-like flexible member sealing transfer chamber, another opening of piston seal transfer chamber.

19. device according to claim 18, wherein, when the top in nipple chamber is positioned at transfer chamber, transfer chamber not with the test chamber fluid connection; When the top in nipple chamber is reversed and is positioned at test chamber, transfer chamber and test chamber fluid connection.

20. device according to claim 18, wherein, the piston and the nipple-like flexible member that are positioned at transfer chamber limit a chamber, and this chamber comprises a passage that is communicated with sample chamber.